WSR 16-20-074 PROPOSED RULES DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed October 3, 2016, 4:48 p.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 16-09-099.
Title of Rule and Other Identifying Information: WAC 246-873-060 Emergency outpatient medications, the pharmacy quality assurance commission is proposing rule language that would amend WAC 246-873-060 to align with RCW 70.41.480 to prescribe prepackaged emergency medications.
Hearing Location(s): Highline Community College, Mt. Constance, 2400 South 240 Street, Des Moines, WA 98198, on November 10, 2016, at 9:00 a.m.
Date of Intended Adoption: November 10, 2016.
Submit Written Comments to: Doreen Beebe, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-2260, by October 31, 2016.
Assistance for Persons with Disabilities: Contact Doreen Beebe by November 3, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: RCW 70.41.480 enacted in 2015, created an inconsistency with WAC 246-873-060. The rule will be amended to align and implement the statute. The current rule limits the distribution of controlled substances to ten rural hospitals.
Reasons Supporting Proposal: Amending the rule will improve public health by removing barriers and facilitating patient's access to appropriate medication therapy when pharmacy services are not available. In addition, amending the existing language will provide clarity and be more reflective of current practices of distributing medications within the emergency department setting.
Statutory Authority for Adoption: RCW 18.64.005.
Statute Being Implemented: RCW 70.41.480.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting: Brett Lorentson, 111 Israel Road S.E., Tumwater, WA 98504-7852, (360) 236-4611; Implementation and Enforcement: Doreen Beebe, 111 Israel Road S.E., Tumwater, WA 98504-7852, (360) 236-4834.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iv) exempts rules that only correct typographical errors, make address or name changes or clarify the language of a rule without changing its effect; and the content which is explicitly and specifically dictated by statute. A preliminary cost-benefit analysis may be obtained by contacting Doreen Beebe, 111 Israel Road S.E., Tumwater, WA 98504-7852, phone (360) 236-4834, fax (360) 236-2260, e-mail Doreen.Beebe@doh.wa.gov.
October 3, 2016
Tim Lynch, PharmD, MS
Chair
AMENDATORY SECTION (Amending WSR 92-12-035, filed 5/28/92, effective 6/28/92)
WAC 246-873-060 Provision of emergency ((outpatient)) department discharge medications when pharmacy services are unavailable.
The ((director of pharmacy)) responsible manager, as defined in WAC 246-869-070, of a hospital or free standing emergency department shall, in ((concert)) collaboration with the appropriate medical staff committee of the hospital ((medical staff)), develop policies and procedures in compliance with RCW 70.41.480, which ((shall)) must be implemented((,)) to provide ((emergency pharmaceuticals to outpatients)) discharge medications to patients released from hospital emergency departments during hours when ((normal)) community or outpatient hospital pharmacy services are not available. The delivery of a single dose for immediate administration to the patient ((shall not be)) is not subject to this regulation. Such policies shall allow the ((designated)) practitioner or registered ((nurse(s) to deliver)) nurse to distribute medications ((other than controlled substances)), pursuant to the policies and procedures ((which shall require that)), as specified in RCW 70.41.480 and the following:
(1) An order of a practitioner authorized to prescribe a drug is presented. Oral or electronically transmitted orders must be verified by the ((prescriber)) practitioner in writing within ((72)) seventy-two hours.
(2) ((The)) A department credentialed pharmacy technician or a licensed pharmacist shall prepackage the medication. Medication ((is)) prepackaged by a ((pharmacist and has a label)) department credentialed pharmacy technician must be checked by a licensed pharmacist. The prepackaged medication must contain any supplemental material provided and an affixed label that contains:
(a) Name, address, and telephone number of the hospital.
(b) The name of the drug (as required by chapter 246-899 WAC), strength and number of units.
(c) Cautionary information as required for patient safety and information on use is provided.
(d) An expiration date after which the patient should not use the medication.
(e) Directions for use.
(3) No more than a ((24-hour)) forty-eight hour supply is provided to the patient except when the pharmacist has informed appropriate hospital personnel that normal services will not be available within ((24)) forty-eight hours. A final quantity of medication supply shall not exceed ninety-six hours.
(4) The ((container is labeled by the designated)) practitioner or registered ((nurse(s))) nurse will ensure the container is labeled before presenting to the patient and shows the following:
(a) Name of patient;
(b) ((Directions for use by the patient;)) Complete directions for use, which should include at a minimum the number of units distributed, frequency, and route of administration;
(c) Date of distribution;
(d) Identifying number (i.e., RX number or similar indicator);
(e) Name of prescribing practitioner;
(f) Initials of the practitioner or registered nurse((;)) who distributed the medication.
(5) A registered nurse or practitioner will distribute prepackaged emergency medications to patients only after a practitioner has counseled the patient on the medication.
(6) The original ((or a direct copy of the)) hard copy or electronically transmitted order by the ((prescriber)) practitioner is retained for verification by the pharmacist after completion by the ((designated)) practitioner or registered ((nurse(s))) nurse and shall ((bear)) contain:
(a) Name and address of patient if not already listed in the medical record;
(b) Date of issuance;
(c) Units issued;
(d) Initials of ((designated)) practitioner or registered nurse.
(((6))) (7) The medications ((to be delivered as emergency pharmaceuticals shall be kept in a secure place)) distributed as discharge medications must be stored in compliance with the laws concerning security and access. They must be stored in or near the emergency ((room)) department in such a manner as to preclude the necessity for entry into the pharmacy when pharmacy services are not available.
(((7) The procedures outlined in this rule may not be used for controlled substances except at the following rural hospitals which met all three of the rural access project criteria on May 17, 1989:
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